Buccal Estrogen in Toothpaste Study: Systemic Absorption of Estradiol When Administered Mixed With Toothpaste in Postmenopausal or Surgically Menopausal Women

NCT00029757 | Completed

• 1 other identifier: NCRR-M01RR02558-1056
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The use of estrogen in postmenopausal (or surgically menopausal) women is a common practice. Compliance is problematic in that estimates show only 1/3 of women use hormone replacement therapy (HRT) and only 30% are compliant. Estrogen has many documented benefits including symptomatic relief of hot flashes, improvement of the dry vagina and dyspareunia. Estrogen has been found to improve bone mineral density and increase the high- density lipoprotein portion of a cholesterol panel. To improve compliance and to provide an alternate method of delivery, we propose the use of estrogen which is admixed in toothpaste and propose to study the absorption, rate of build-up and rate of decline. Hypothesis: Estrogen can potentially be absorbed systemically when toothpaste is admixed with estradiol and is applied in a timed, consistent fashion to postmenopausal or surgically postmenopausal women, not on HRT. Absorption takes place across the buccal mucosa. Specific Aims:1) To estimate the systemic absorption of estrogen from daily use of estrogen containing toothpaste. 2\) To estimate the rate of build-up of serum estrogen levels based upon daily use of toothpaste containing estrogen for eight days. 3\) To estimate the rate of decline in serum estrogen levels when the use of estrogen containing toothpaste is discontinued for a week.

Conditions

Menopause; Postmenopause

Keywords

Surgical menopause

Interventions

Estrogen DRUG

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

Postmenopausal women or surgically menopausal women, not on hormone replacement therapy for at least 3 weeks

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Center for Research Resources (NCRR): lead

Study Sites (1)

University of Texas--Houston Medical School

Houston, Texas, 77030, United States

Location

MeSH Terms

Interventions

Estrogens

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 22, 2002
• First Posted: January 23, 2002
• Last Updated: November 7, 2005

Record last verified: 2003-12

Locations

US (1)